Class Class II
ProLift Wedge Expandable Spacer System (K242826)
Description
ProLift Wedge Expandable Spacer System by Life Spine, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242826
Clearance Date2024-10-08
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242826
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ProLift Wedge Expandable Spacer System (K242826) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203361 | ProLift Wedge Expandable Spacer System | Life Spine, Inc. | 2021 |
| K190488 | ProLift Expandable System | Life Spine, Inc. | 2019 |
| K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 |
| K153627 | NuVasive® TLX Interbody System | Nu Vasive, Incorporated | 2016 |
Trace the full predicate network for K242826
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.